Numerous serious medical issues arise within the proximal and/or distal aspect of the Gastrointestinal or GI tract. Many of these conditions are related to wall perforation allowing intra luminal content exposure to the abdominal cavity with morbid consequences. Treatment often is difficult and with undesirable outcomes. In the event of post-operative complication of the proximal stomach in the case of a sleeve gastrectomy a staple line dehiscence represents the most feared complication due to the futility of the few available treatment options. Currently the intraluminal expandable metallic covered stents are considered the treatment of choice with a high associated cost and significant complication rate including migration, stomach perforation and inability of removal requiring total gastrectomy.
Staple line dehiscence or leakage can create a state of sepsis which is technically challenging and potential harmful to patients.
Current self-expanding stents have high rates of distal mobility, may cause bleeding, reflux, non-isolation and prolong time to resolution. Also, there may be a high cost associated with the use of a non FDA approved application.
Currently, a non-FDA approved esophageal self-expanding esophageal stent is being used with moderate resolution rates. While this conventional device provides some improvement over prior approaches, it is desirable to provide for improved isolation, distal feeding and negative pressure application which may aid in hastening resolution, recover and potential for prevention. Conventional devices and approaches do not address these desired improvements.
Improvements to these conventional approaches to treatment of conditions within the GI tract are desirable.